Biomarkers for Diagnosis of Lung Nodules

The Biomarkers for Diagnosis of Lung Nodules Study is a prospective study of a cohort of 500
individuals with lung nodules of indeterminate etiology that are identified by CT scans.
Either biopsy or repeat CT scans must be clinically indicated to determine the etiology of
the nodule. Patients will be asked to allow investigators access to CT scan images and
spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course
of the study. Patients will also be asked to allow investigators to access pathology records
if a biopsy or surgical excision of the nodule is clinically indicated.

Inclusion Criteria:

1. Adult 18-85 years of age

2. Patients referred to pulmonologists, oncologists, or thoracic surgeons for the
evaluation of peripheral lung nodules found on CT scan.

3. Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the
etiology of the nodule.

4. One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.

5. Patients must be fully informed of the investigational nature of the procedure and
sign an informed consent.

Exclusion Criteria:

1. Lung nodules or masses greater than 30 mm in the greatest dimention.

2. Lung nodules that have solid calification.

3. Lung nodules or masses with CT evidence of partial or complete obstruciton of a lobar
bronshus, mainstem bronchus or the trachea.

4. No prior cancer with the exception of non-melanoma skin cancer.

5. Life expectany of < 6 months

6. Any indifidual who does not give oral and written consent for participation -